The Recall Desk
SevereFDA (Drugs)·D-0102-2024·Announced 2023-11-15

Pfizer Lidocaine Injection Recall: Glass Particulates in Injectable Medication

Pfizer is recalling 3,200 vials of Lidocaine Hydrochloride 2% Injection due to the presence of glass particulates. The injectable medication was distributed nationwide in the US and Puerto Rico.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall. Per the severity rubric, FDA Class I recalls warrant a minimum severity score of 4. Glass particulates in an injectable medication pose a serious risk of injury upon administration, even though no illnesses or injuries have been reported in the source text.

Plain-English summary

Pfizer Inc. is recalling 3,200 vials of Lidocaine Hydrochloride 2% Injection (NDC 0409-4903-11) distributed by Hospira Inc. due to the presence of glass particulates. The affected product is a 2% Lidocaine HCl Injection, USP containing 100mg/5mL (20mg/mL) in glass ABBOJECT Unit of Use Syringes, packaged as 1 vial and injector per carton.

The recalled lot is GH6567 with an expiration date of July 1, 2024. The product was distributed nationwide in the United States and Puerto Rico and was not distributed to government accounts or foreign consignees.

The presence of glass particulates in an injectable medication creates a risk of injection of foreign material into tissue. Consumers should not use the affected medication. Patients and healthcare providers who received this product should contact their pharmacist or healthcare provider immediately with the lot number and expiration date.

The recalled product

Product
LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
Brand
LIDOCAINE HYDROCHLORIDE
Manufacturer
Pfizer Inc.
Hazard
  • glass-contamination

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot#: GH6567
  • Exp. 7/1/2024

Distribution

Distributed nationwide across the United States.